The present invention relates to a composition for treating warts including, but not limited to, common warts, plantar warts, flat warts, and filiform warts. The present invention is not to be limited to treating plantar warts. However, as a manner of convenience and to explain some of the types of problems that the present invention addresses, problems associated with the current modalities of plantar warts are discussed.
Plantar warts are epidermal lesions caused by an infection by the human papilloma virus (HPV), a double-stranded DNA virus. HPV has over a 100 subtypes, but those most found in plantar warts are HPV 1, 2, 4, and 10. Plantar warts are generally benign and usually self-limiting lesions, but are often painful and can be debilitating. The incidence of plantar warts is 1 to 2 percent in the general population, with 60% of cases resolving spontaneously within a two year period. Although multiple treatments have been proposed over the years, to date there is no uniformly effective treatment for warts.
Aggressive treatments for the recalcitrant wart include surgical excision, laser, and cryotherapy treatments. Because these approaches are often painful and do not guarantee success, doctors and patients may opt for a less invasive treatment, or patients may try to treat themselves at home.
The most common at home treatment for warts is a non-prescription salicylic acid preparation, usually a gel or cream, containing concentrations ranging from 10-60% salicylic acid. Salicylic acid acts in a catalytic manner breaking down protein (keratin) found in the wart and the thick layer of dead skin on top of the wart. To be effective, these preparations need to be applied several times a day over a series of weeks, even months. As such, efficacy is dependent on patient compliance with repeated applications. Even with patient compliance, less than half who use salicylic acid experience success. Therefore, alternative treatments have been proposed.
Several topical preparations are known in the art for use in the treatment of warts. As already noted, known treatments are disadvantageous in that they typically require repeated daily applications. Further, with many of these treatments, the patient needs to debride the wart between applications to provide maximum contact and penetration of the medication to the wart.
U.S. Pat. No. 6,599,513 is directed to emulsion formulations that are disclosed as optionally including various anti-psoriasis actives. These formulations require the presence of substantially intact oil bodies derived from a cell.
U.S. Patent Pub. No. 2003/0235627 to Maibach is directed to a wart treatment composition, and identifies 5-FU and salicylic acid as individual agents that have been tried in the past for the treatment of warts, but are disadvantageous due to potential damage to healthy skin and potential toxicity, respectively. Maibach requires topical delivery of its active ingredients in a basic carrier (i.e. pH of 7.5 to 13.0), as a strategy for enhancing the permeability of skin or mucosal tissue to the active agent.
Another home remedy for the treatment of warts is duct tape. Unlike most wart treatments, duct tape does not require repeated daily applications and works simply by occluding the wart, thereby creating a macerating and keratolytic environment. However, duct tape alone may not provide resolution of warts.
For these and other reasons, there is a need for the present invention.
Accordingly, it is an object of the present invention to provide a composition effective for the treatment of warts.
Another object of the present invention is to provide a composition effective for the treatment of warts that requires only once daily application.
Still another object of the present invention is to provide a method using a composition that is effective in the treatment of warts.
A further object of the present invention is to provide a kit effective for the treatment of warts that comprises a composition containing 5-FU and salicylic acid.
The method and means of accomplishing each of the above objectives as well as others will become apparent from the detailed description of the invention which follows hereafter.